Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K053388 |
Device Name |
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION |
Applicant |
PURITAN BENNETT CORP. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Applicant Contact |
JAMES BONDS |
Correspondent |
PURITAN BENNETT CORP. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Correspondent Contact |
JAMES BONDS |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 12/05/2005 |
Decision Date | 04/04/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|